Services Auditing services
Ensuring Quality in Clinical Investigations
Strategic and Customized
With Biotex CRO+, you can expect a transparent and constructive audit process that identifies strengths and offers strategic recommendations for improvement.
Our specialized auditing services are tailored to instill confidence by providing thorough assessments, guaranteeing adherence to the highest standards, and establishing a collaborative partnership to enhance the efficiency and quality of your clinical investigations.
At Biotex CRO+, our commitment extends beyond the audit, as we actively collaborate with you to implement best practices and drive continuous improvement. We also understand the critical role that a reliable QMS, a trustworthy team, and efficient clinical investigation sites play in the success of your projects.
Choosing Biotex CRO+ as your auditing partner is a strategic investment in the success of your clinical endeavors. By partnering with us, you gain an auditing service and a dedicated ally in advancing clinical research, ensuring compliance, and achieving unparalleled excellence in your operations.
Compliant with Standards and Ethical Practices
Biotex CRO+ is a valuable partner in providing external audit services for a Sponsor/CRO or investigation site, ensuring a robust evaluation process. We align our practices with the ISO 14155 standard for Clinical Investigation of Medical Devices in Human Subjects, adhering to Good Clinical Practice (GCP).
Our audit process categorizes findings into Minor Nonconformity, Major Nonconformity, or Observations, providing a detailed understanding of the audit outcomes. You’ll also benefit from our collaborative efforts to ensure adherence to our defined procedure as various stakeholders, including auditors, audit team leaders, and regulatory personnel, work together to maintain the integrity of the audit process.
Four Reasons to Request for Auditing Services
01
ROUTINE QUALITY ASSURANCE
02
ASSESSING MONITORING EFFECTIVENESS
03
PREPARING FOR REGULATORY INSPECTIONS
04
AS SUGGESTED BY REGULATORY AUTHORITIES
WHAT OUR AUDITING SERVICES INCLUDE
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Investigator Assessment and Site Selection
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Monitoring (Serious/Non-Compliance Issues)
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Evaluations (Outsourced Duties Oversight)
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Internal Approval Reviews, Selection, and Training
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Investigational Product Control
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Procedure Adherence Assessment
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CRF Accuracy and Completeness Verification
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Financial Disclosures and Agreements Review
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Data Handling, Analysis, and Control of Documentation Assessment
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Amendments to Clinical Documents Management
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Adherence to Computerized Systems (EDC, etc.) Verification
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Source Document Organization, Storage, and Completeness Review
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Regulatory Authority and EC/IRB Reporting Requirements Management
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Evaluation (Monitoring Procedures and Effectiveness)
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Clinical Research Organization and Assessment
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Ethical Considerations Verification
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Safety Evaluation and Adverse Event Reporting Assessment
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Patient Confidentiality Verification
WHY INTERNAL AUDITS ARE ESSENTIAL TO YOUR STUDY
At Biotex CRO+, our commitment to providing unparalleled auditing services is underpinned by the exceptional qualifications and rigorous training of our auditors. We ensure our audit team surpasses the minimum requirements outlined in ISO 14155, encompassing education, experience, and specialized training.
We commit to engaging in a collaborative process with you as our auditors meticulously review the Audit Plan to align with specific objectives and expectations and ensure a tailored approach that addresses the unique nuances of your clinical operations. We also recognize the importance of transparency and communication throughout the auditing process, fostering a partnership beyond the examination.
During internal audits, our thoroughness is reflected in our detailed Audit Reports, providing you with a comprehensive overview of the audit, including Sponsor/CRO/site details, audit dates, staff present, identified findings, and an overall assessment. This meticulous documentation provides transparency and is a valuable resource to help you understand the nuances of the audit so you can make informed decisions for continuous improvement.
why choose Biotex
For Auditing services?
COLLABORATIVE
Prepare for challenging regulatory inspections without worries. Our audit team will collaborate with you to ensure a seamless process, providing you with accurate evaluations and expert recommendations to help you improve your clinical investigation.
TRANSPARENT
We'll thoroughly examine your documentation to ensure compliance with ethical considerations and validate adherence to data protection requirements while providing transparency in our evaluations and strategic recommendations to help you make informed decisions.
EFFICIENT
Biotex CRO+ is committed to performing an expedited audit of your chosen study site with minimal supervision, saving you time and resources without compromising the delivery of our accurate evaluations and assessments that can be valuable resources to help you meet inspection and regulatory requirements for your particular study.
YOUR SUCCESS BEGINS HERE
Partner with us to ensure the validity of the outcomes of your clinical investigation.
At Biotex CRO+, you’ll have access to an expert team of auditors with robust qualifications and a collaborative and transparent auditing process. Our commitment extends beyond the evaluation phase as we work with you to interpret findings, implement corrective actions, and drive continuous improvement in your clinical operations.
Contact us today to embark on a journey of reliability, transparency, and continuous improvement in your chosen QMS, CRO, and clinical investigation sites.
Start Your Journey Now
Embark on the conclusive phase of your clinical trial with confidence, guided by our expertise and commitment to robust auditing services.